Medical Devices Quality Assurance Specialist

4 days ago


Mumbai, Maharashtra, India Lifelancer Full time

At Lifelancer, we're committed to empowering talent in Life Sciences, Pharma, and IT. We're seeking a skilled Medical Devices Quality Assurance Specialist to join our team.

Lifelancer is a leading talent-hiring platform that connects professionals with exciting opportunities in pharma, biotech, health sciences, healthtech, and IT domains.

We offer a dynamic work environment, flexible arrangements for better work-life balance, generous paid leaves, medical benefits, pension, and insurance policies. Our comprehensive training and development assistance will help you grow professionally and personally.

We value diversity and are an equal opportunity employer. If you're passionate about quality assurance and have a strong background in medical devices, we'd love to hear from you

About the Role:

Salary Estimate: $80,000 - $110,000 per annum

This is a full-time position based in India, offering a competitive salary package. The role involves planning and conducting audits/assessments in accordance with ISO 13485, EU MDR, and MDSAP standards.

  • Conducting audits (either desk-based or on client sites) in line with established procedures to maintain high-quality service delivery.
  • Completing chargeable work within budgeted timeframes to ensure customer satisfaction and business efficiency.
  • Collaborating with a team of auditors/assessors to achieve technical compliance and accreditation requirements.

We require a candidate with at least 10 years of professional experience in relevant healthcare products or related activities, including quality management, regulatory affairs, and auditing.

The ideal candidate should possess excellent knowledge of medical device management systems, standards, and auditing techniques. They should also be familiar with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, and MDSAP.

You'll be responsible for reviewing audit packs, examining technical documentation, and managing your workload effectively. Experience as a registered IRCA lead auditor or equivalent registration under other recognized bodies is highly desirable.

We're looking for someone who can work independently and collaboratively as part of a team. If you have a solid understanding of non-active devices, sterilization processes, and risk management principles, we'd love to hear from you



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